FDA.reportPublic FDA data

SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-602
11-digit product format
445230602
Labeler code
44523
Product ID
44523-602_47e8280b-fd31-6274-e063-6394a90ad3b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-04-30
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFACETAMIDE AND SULFUR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-602-01SODIUM SULFACETAMIDE AND SULFUR25 g in 1 BOTTLE, PLASTICLOTION256
44523-602-01SODIUM SULFACETAMIDE AND SULFUR1 in 1 CARTONLOTION16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ISODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-602SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 2 package rows20230926_1352eff6-8b9e-473d-9acf-c0086e1d0917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionPSN1352eff6-8b9e-473d-9acf-c0086e1d09176
1005856sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical LotionSCD1352eff6-8b9e-473d-9acf-c0086e1d09176
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionSY1352eff6-8b9e-473d-9acf-c0086e1d09176
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical SuspensionSY1352eff6-8b9e-473d-9acf-c0086e1d09176

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44523-602-01445230602011 BOTTLE, PLASTIC in 1 CARTON (44523-602-01) / 25 g in 1 BOTTLE, PLASTIC2011-04-300000-00-00NoNoCurrent